Endothelial Hyperpolarization in Humans

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

174 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-07-31

Study Completion Date

2013-01-31

Brief Summary

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The purpose of this study is to elucidate the role Endothelium-Derived Hyperpolarizing Factor (EDHF) plays in dilating blood vessels and whether it differs between healthy people and those with high cholesterol. A second purpose of the study is to determine the identity of EDHF.

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Detailed Description

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The vascular endothelium synthesizes at least four potent vasodilator substances: nitric oxide (NO), prostacyclin, carbon monoxide and endothelium-derived hyperpolarizing factor (EDHF) that contribute to vasodilator tone, and to inhibition of platelet activation and inflammation. EDHF release is stimulated by receptor-dependent agonists such as acetylcholine and bradykinin (BK), and leads to hyperpolarization of the underlying smooth muscle cells presumably by opening Ca2+-activated K+ channels. Indirect pharmacological evidence suggests that EDHF is a cytochrome P450-derived arachidonic acid metabolite, presumably an epoxide. Although the pivotal role of NO to conduit vessel dilation in response to acute increases in shear stress is well known, its' contribution to dilation with sustained increases in flow are minimal, and may be due to EDHF release.

Conditions

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Hyperlipidemia

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Healthy Controls

Healthy subjects had venous occlusion plethysmography after intra-arterial infusions of saline, L-NG-monomethyl Arginine (L-NMMA), Tetraethylammonium (TEA), fluconazole, bradykinin, sodium nitroprusside and acetylcholine

Group Type EXPERIMENTAL

Tetraethylammonium (TEA)

Intervention Type DRUG

5 minute intra-arterial infusion of Tetraethylammonium at 1 mg/min

L-NG-monomethyl Arginine (L-NMMA)

Intervention Type DRUG

5 minute intra-arterial infusion of L-NMMA 8 μmol/min

Bradykinin

Intervention Type DRUG

Intra-arterial infusion of bradykinin at 100, 200, and 400 ng/min. Each dose will be given for 5 minutes.

Sodium nitroprusside

Intervention Type DRUG

Intra-arterial infusion of sodium nitroprusside at 1.6 and 3.2 mg/min. Each dose will be given for 5 minutes.

Acetylcholine

Intervention Type DRUG

Intra-arterial infusion of acetylcholine at 7.5, 15 and 30 μg/min. Each dose will be given for 5 minutes.

Saline

Intervention Type DRUG

5 minute intra-arterial infusion of 0.9% saline at 2.5ml/min

Fluconazole

Intervention Type DRUG

5 minute intra-arterial infusion of fluconazole at 0.4 mg/L/min

Risk Factors

Non-hypertensive subjects with cardiovascular risk factors had venous occlusion plethysmography after intra-arterial infusions of saline, L-NG-monomethyl Arginine (L-NMMA), Tetraethylammonium (TEA), fluconazole, bradykinin, sodium nitroprusside and acetylcholine

Group Type EXPERIMENTAL

Tetraethylammonium (TEA)

Intervention Type DRUG

5 minute intra-arterial infusion of Tetraethylammonium at 1 mg/min

L-NG-monomethyl Arginine (L-NMMA)

Intervention Type DRUG

5 minute intra-arterial infusion of L-NMMA 8 μmol/min

Bradykinin

Intervention Type DRUG

Intra-arterial infusion of bradykinin at 100, 200, and 400 ng/min. Each dose will be given for 5 minutes.

Sodium nitroprusside

Intervention Type DRUG

Intra-arterial infusion of sodium nitroprusside at 1.6 and 3.2 mg/min. Each dose will be given for 5 minutes.

Acetylcholine

Intervention Type DRUG

Intra-arterial infusion of acetylcholine at 7.5, 15 and 30 μg/min. Each dose will be given for 5 minutes.

Saline

Intervention Type DRUG

5 minute intra-arterial infusion of 0.9% saline at 2.5ml/min

Fluconazole

Intervention Type DRUG

5 minute intra-arterial infusion of fluconazole at 0.4 mg/L/min

Interventions

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Tetraethylammonium (TEA)

5 minute intra-arterial infusion of Tetraethylammonium at 1 mg/min

Intervention Type DRUG

L-NG-monomethyl Arginine (L-NMMA)

5 minute intra-arterial infusion of L-NMMA 8 μmol/min

Intervention Type DRUG

Bradykinin

Intra-arterial infusion of bradykinin at 100, 200, and 400 ng/min. Each dose will be given for 5 minutes.

Intervention Type DRUG

Sodium nitroprusside

Intra-arterial infusion of sodium nitroprusside at 1.6 and 3.2 mg/min. Each dose will be given for 5 minutes.

Intervention Type DRUG

Acetylcholine

Intra-arterial infusion of acetylcholine at 7.5, 15 and 30 μg/min. Each dose will be given for 5 minutes.

Intervention Type DRUG

Saline

5 minute intra-arterial infusion of 0.9% saline at 2.5ml/min

Intervention Type DRUG

Fluconazole

5 minute intra-arterial infusion of fluconazole at 0.4 mg/L/min

Intervention Type DRUG

Other Intervention Names

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Methylarginine Nitropress Diflucan

Eligibility Criteria

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Inclusion Criteria

* Hyperlipidemic (LDL \> 140)
* Healthy Volunteer

Exclusion Criteria

* Pregnancy
* Diabetes mellitus
* Cardiovascular Disease
* Hypertension
* Use of any regular medications
* Renal insufficiency
* Smoking (current or within the past 5 years)
* Bleeding disorder

Minimum Eligible Age

21 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes